Company
Abbott Medical Optics Inc. (AMO)
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
24recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2017 | Abbott Medical Optics Inc. (AMO) AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use. Terminated |
MLZ | K081681 |
| Apr 1, 2017 | Abbott Medical Optics Inc. (AMO) Healon V, Part No. 10290045 Terminated |
LZP | None listed |
| Apr 1, 2017 | Abbott Medical Optics Inc. (AMO) Healon Pro, Part No. 10270012 Terminated |
LZP | None listed |
| Apr 1, 2017 | Abbott Medical Optics Inc. (AMO) Healon 5 Pro, Part No. 10270015 Terminated |
LZP | None listed |
| Apr 1, 2017 | Abbott Medical Optics Inc. (AMO) Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012 Terminated |
LZP | None listed |
| Apr 1, 2017 | Abbott Medical Optics Inc. (AMO) Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014 Terminated |
LZP | None listed |
| Apr 1, 2017 | Abbott Medical Optics Inc. (AMO) Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701 Terminated |
LZP | None listed |
| Sep 21, 2016 | Abbott Medical Optics Inc. (AMO) AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002
The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens ha Terminated |
HQL | None listed |
| Sep 21, 2016 | Abbott Medical Optics Inc. (AMO) TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00
The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopi Terminated |
HQL | None listed |
| Sep 21, 2016 | Abbott Medical Optics Inc. (AMO) TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery
System, Model No. PCB00V
The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a Terminated |
HQL | None listed |
| Sep 21, 2016 | Abbott Medical Optics Inc. (AMO) TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00
The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractou Terminated |
HQL | None listed |
| Sep 21, 2016 | Abbott Medical Optics Inc. (AMO) SENSAR 1-Piece IOL, Model No. AAB00
The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular catara Terminated |
HQL | None listed |
| Sep 21, 2016 | Abbott Medical Optics Inc. (AMO) TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V
The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been re Terminated |
HQL | None listed |
| Sep 21, 2016 | Abbott Medical Optics Inc. (AMO) TECNIS 1-Piece IOL, Model No. ZCB00
The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular catara Terminated |
HQL | None listed |
| Sep 21, 2016 | Abbott Medical Optics Inc. (AMO) TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00
The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a Terminated |
HQL | None listed |
| Sep 21, 2016 | Abbott Medical Optics Inc. (AMO) TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00;
The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopi Terminated |
HQL | None listed |
| Sep 21, 2016 | Abbott Medical Optics Inc. (AMO) SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e
The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed b Terminated |
HQL | None listed |
| Dec 12, 2014 | Abbott Medical Optics Inc (AMO) Abbott Healon EndoCoat Ophthalmic Viscosurgical Device
3% sodium hyaluronate
0.85 mL 30 mg/mL
Sterile A Solution
Sterile EO Packaging and Cannula
Product of USA
Abbott Healon Duet Dual Pack
0.55 ml O Terminated |
LZP | None listed |
| Mar 9, 2013 | Abbott Medical Optics Inc (AMO) AMO Sensar Intraocular Lenses (IOLs), Model AR40e,
Sensar Foldable IOL with OptiEdge
Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extr Terminated |
HQL | None listed |
| Nov 23, 2011 | Abbott Medical Optics Inc (AMO) Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter.
The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for Terminated |
HQL | None listed |
| Nov 23, 2011 | Abbott Medical Optics Inc (AMO) Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter.
The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for Terminated |
HQL | None listed |
| Nov 2, 2010 | Abbott Medical Optics Inc (AMO) AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml).
Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear. Terminated |
LPN | None listed |
| Nov 2, 2010 | Abbott Medical Optics Inc (AMO) AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml).
Cleans, rinses, disinfects, and stores all soft contact lenses and helps Terminated |
LPN | K014202 |
| Jan 12, 2010 | Abbott Medical Optics Inc (AMO) AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00) Terminated |
HQL | None listed |